NCT01579435

Brief Summary

The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) delivered over the motor cortex or the cerebellum can improve essential tremor and to identify the cerebral mechanisms involved in these potential effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 11, 2013

Status Verified

April 1, 2013

Enrollment Period

1 year

First QC Date

April 5, 2012

Last Update Submit

April 10, 2013

Conditions

Essential Tremor

Keywords

essential tremorprimary motor cortexcerebellumtranscranial direct current stimulationelectrophysiology

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in tremor amplitude on accelerometric recording 10 minutes after the end of tDCS

    10 minutes after the end of tDCS

Secondary Outcomes (3)

  • Change from baseline in tremor amplitude on electromyographic recordings

    During tDCS (expected average of 15 minutes), 10 and 60 mn after the end of tDCS

  • Change from baseline in tremor amplitude on digitized tablet

    During tDCS (expected average of 15 minutes), 10 and 60 mn after the end of tDCS

  • Change from baseline in tremor amplitude on accelerometric recording

    During tDCS (expected average of 15 minutes) and 60 minutes after the end of tDCS

Study Arms (2)

Therapeutic tDCS

EXPERIMENTAL

6 patients with essential tremor

Device: transcranial direct current stimulation

Physiopathological tDCS

EXPERIMENTAL

6 patients with essential tremor

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulationDEVICE

Active stimulation: duration: 20 mn, intensity: 2 mA; localisation : motor cortex or cerebellum; Placebo stimulation: duration: 9 seconds, intensity: 2 mA; localisation : motor cortex or cerebellum;

Physiopathological tDCSTherapeutic tDCS

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age ≥ 18 years and \< 50 years
  • Important essential tremor (bilateral postural and/or action tremor since more than one year)
  • Normal physical and neurological examination, except for essential tremor
  • Insufficient efficiency of usual essential tremor's treatment
  • No treatment altering the cortical excitability
  • Agreement to use a medically acceptable method of contraception throughout the study for female of childbearing potential

You may not qualify if:

  • Cervical tremor
  • Current neurological or psychiatric illness other than essential tremor
  • Individual who is on medication which is known to lower seizure threshold
  • Previous history of seizure(s), malaise or current active epilepsy
  • Contraindication for MRI or TMS study
  • Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control
  • Individual who have MMS ≤ 24/30 or patients legally protected or inability to provide an informed consent
  • Simultaneous participation in another clinical trial
  • Patients who are not enrolled at social security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut du Cerveau et de la Moelle, Hôpital Pitié-Salpétrière

Paris, 75651, France

Location

MeSH Terms

Conditions

Essential Tremor

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Emmanuel Flamand-Roze, MD

    Institut du Cerveau et de la Moelle et Fédération de Neurologie de l'Hôpital Pitié-Salpétrière, Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2012

First Posted

April 18, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 11, 2013

Record last verified: 2013-04

Locations

FR(1)